Medical Marijuana (Cannabinoid-Derived Products) for Cancer Patients 38 accc-cancer.org | May–June 2020 | OI BY MELODY CHANG, RPH, MBA, BCOP annabis, also known as marijuana, or called a vast number of other slang terms like weed, herb, pot, grass, bud, ganja, and Mary Jane originated in Central Asia but is grown Each state has its own list of the Cworldwide today. Cannabis use for medicinal purposes dates qualifying conditions for which it will back at least 5,000 years, with the earliest reported use being in China around 2700 BC for the relief of pain and cramps.1 allow patients to use medical marijuana. In the United States, cannabis is still a controlled substance These qualifying conditions are different and is classified as a Schedule I agent (a drug with a high potential for abuse and currently no accepted medical use). The U.S. Food in each state; however, in many states and Drug Administration (FDA) has not approved cannabis as a number of conditions are cancer a treatment for cancer or any other medical condition. By federal law, the possession of cannabis is illegal, except within approved related—chemotherapy-induced nausea research settings. However, a growing number of states, territories, and vomiting, anxiety, hepatitis C, and the District of Columbia have enacted laws that decriminalized the recreational and/or medicinal use of marijuana in that specific HIV/AIDS, cachexia (wasting syndrome), area. Cannabis is the fastest growing industry in the world. Accord- and inflammatory bowel disease. ing to Arcview’s market research, regulated marijuana sales in North America totaled $6.9 billion in 2016. Sales are projected to increase to $21.6 billion by the year 2021.2 Over the last few decades, there has been significant interest in the potential use of History and Overview marijuana for a variety of medical conditions. There are more Cannabis is a genus of the family Cannabaceae and has generally than 60 U.S. and international health organizations that support been recognized to contain three main species: sativa, indica, and granting patients immediate legal access to medicinal marijuana ruderalis. Cannabis sativa and Cannabis indica are both prevalent under a physician’s supervision.3 in the United States and other parts of the world. Cannabis sativa This article is intended to provide a general introduction and has been employed for thousands of years, primarily as a source overview regarding some of the important aspects and contem- of a stem fiber (both the plant and the fiber, termedhemp ) and porary issues encountered when navigating the field of medical a resinous intoxicant (the plant and its drug preparations, com- marijuana. monly termed marijuana).4 OI | May–June 2020 | accc-cancer.org 39 Figure 1. A Timeline of Cannabis History in the United States Compassionate Use Marihuana Tax Investigational New Cannabis was Act imposed a U. S. Congress Drug program is introduced into levy of 100 per passed the Boggs established; cannabis Western medicine by ounce of cannabis Act and included is distributed to Surgeon W.B. for non-medical cannabis with patients on a 7 10 11 O’Shaughnessy. use.10 narcotic drugs. case-by-case basis. 1839 1851 193 1942 1951 190 198 1992 Cannabis was Cannabis was Controlled Distribution of included in the removed from the Substance Act cannabis through third edition of the 12th edition of the passes; marijuana the compassionate Pharmacopeia of Pharmacopeia of is classified as a use program is the United States.8 the United Schedule I drug.10 closed to new States.10 patients.11 Traditionally, Cannabis sativa plants are tall, reaching heights Pharmacopoeia of the United States (USP). Subsequent revisions of up to 20 feet, loosely branched, and have long, narrow leaves. of the Pharmacopoeia described in detail how to prepare extracts On the other hand, Cannabis indica plants are short and densely and tinctures of dried cannabis flowers to be used as an analgesic, branched and have wider leaves. hypnotic, and anticonvulsant.8 The cannabis plant produces a resin containing compounds Cannabis was included in marketed products sold in the United called cannabinoids. Cannabinoids, also known as phytocanna- States by Eli Lilly and Company and other pharmaceutical com- binoids, are chemicals in cannabis that cause drug-like effects in panies for the treatment of a variety of conditions and/or disorders, the body, including the central nervous system and the immune including insomnia, migraines, and rheumatism.9 system. To date, more than 100 different cannabinoids have been Growing concerns about cannabis in the early 1900s resulted identified. Among these, Δ9-tetrahydrocannabinol (THC) has in it being outlawed in several states, and the U.S. Treasury received the most attention for being responsible for the intoxi- Department introduced the Marihuana Tax Act in 1937. This cated state (psychoactive) sought by recreational cannabis users. Act imposed a levy of $1.00 per ounce for the medicinal use of Another active cannabinoid is cannabidiol (CBD), which may cannabis and $100 per ounce for non-medical use.10 In 1942, the relieve pain and lower inflammation without causing a “high” American Medical Association removed cannabis from the 12th from the THC.6 The highest concentration of cannabinoids is edition of the Pharmacopeia of the United States.10 In 1951, found in the female flowers of the plant. Congress passed the Boggs Act, which for the first time classified In general, marijuana refers only to the parts of the plant or cannabis with narcotic drugs.10 With the passage of the Controlled derivative products that contain substantial levels of THC. Under Substances Act in 1970, cannabis was classified by Congress as U.S. law, cannabis plants with very low levels of THC (no more a Schedule I drug. Drugs that are Schedule I are distinguished as than 0.3 percent) are not considered marijuana but instead are having no currently accepted medicinal use in the United States. industrial hemp. Other Schedule I substances include heroin, lysergic acid dieth- Cannabis use for medicinal purposes dates back thousands of ylamide, mescaline, and methaqualone.10 Despite its designation years ago. It was introduced into Western medicine in 1839 by as having no medicinal use, cannabis was distributed by the U.S. W.B. O’Shaughnessy, a surgeon who learned of its medicinal government to patients on a case-by-case basis under the Com- properties while working in India for the British East India Com- passionate Use Investigational New Drug program established pany. Its use was credited with reported analgesic, sedative, in 1978. Distribution of cannabis through this program was anti-inflammatory, antispasmodic, and anticonvulsant effects.7 closed to new patients in 1992.11 Figure 1, above, shows a timeline In 1851, cannabis was included in the third edition of the of cannabis’s history in the United States. 40 accc-cancer.org | May–June 2020 | OI Legal Status: Federal and State Laws is a fee for applications, and each state has different limits on the Although federal law prohibits the use of cannabis, some states amounts patients are permitted to purchase. In most cases, the have enacted laws that legalized the recreational and/or medicinal purchasing cost of medical marijuana or medical CBD is not use of marijuana in that specific state.6 In 1996, California voters covered by insurance. passed Proposition 215, making California the first state in the To become a certified marijuana physician, a physician must United States to permit the use of medical marijuana.12 Colorado hold an active license, take a required course, and pass an exam. and Washington became the first two states to legalize the recre- This process varies by state. After completion of the state require- ational use of cannabis in 2012. ments, physicians may apply for certification. States with Medical and Recreational Marijuana Laws Dispensing of Medical Marijuana or CBD Thirty-three states and the District of Columbia have passed As of November 30, 2019, 33 states, the District of Columbia, legislation legalizing marijuana for medical use. Of those, five Guam, Puerto Rico, and the U.S. Virgin Islands have passed have established a role for pharmacists in the dispensing medical marijuana laws (see Figure 2, page 42).13 Among them, process:14 10 states, the District of Columbia, and Guam also have legalized • Arkansas requires every marijuana dispensary to appoint a marijuana for recreational use. Those 10 states are Alaska, pharmacist consultant. California, Colorado, Maine, Massachusetts, Colorado, Nevada, • Connecticut permits only pharmacists to apply for and obtain Oregon, Vermont, and Washington.13 a marijuana dispensary license. States with Medical Cannabidiol (CBD) Laws • Minnesota permits only pharmacists to give final approval There are an additional 14 states—Alabama, Georgia, Indiana, for the distribution of medical marijuana to a patient. Iowa, Kansas, Kentucky, Mississippi, North Carolina, • New York requires a pharmacist to be on the premises and South Carolina, Tennessee, Texas, Virginia, Wyoming, and supervise the activities within a marijuana dispensing facility Wisconsin—where the use of medical marijuana has not been whenever the facility is open or in operation. legalized but a medical CBD law allowing for the use of cannabis • Pennsylvania requires primary marijuana dispensing facilities to have a physician or pharmacist on site when the facility is extracts that are high in CBD but minimum in THC has been open to receive patients and caregivers. passed.13 This is only in instances where a patient with a state- qualifying condition is recommended CBD by his or her Under federal law, no individual, including pharmacists, can provider.13 legally dispense medical marijuana, even in states that have passed Individual state laws are all different. Under Florida’s medical medical marijuana legislation.